Trial Outcomes & Findings for Patient-Reported Outcomes Measurement Information System Integration Into Rheumatology Clinical Practice (NCT NCT05026853)
NCT ID: NCT05026853
Last Updated: 2024-04-30
Results Overview
Documentation in EMR notes will be categorized as either 'yes' or 'no' and identified through EMR data pulls. Percent of appointments is shown by the count (and percentage) of participants for whom PROMIS scores were documented in the EMR for their appointment.
COMPLETED
NA
110 participants
Up to 3 months
2024-04-30
Participant Flow
Participant milestones
| Measure |
PRO Integration Into Clinical Practice
PRO scores will be shared with patients and healthcare providers (HCPs) via an emailed report card
PRO Integration into Clinical Practice: HCPs will document their discussion and recommendations/referrals in MiChart (Epic EMR)
|
Usual Care
Patients and HCPs will not receive an emailed PROMIS score report. PROMIS scores, however, will be available in the EMR as usual.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
Week 2 Follow-up
|
35
|
45
|
|
Overall Study
Week 12 Follow-up
|
30
|
39
|
|
Overall Study
COMPLETED
|
30
|
39
|
|
Overall Study
NOT COMPLETED
|
25
|
16
|
Reasons for withdrawal
| Measure |
PRO Integration Into Clinical Practice
PRO scores will be shared with patients and healthcare providers (HCPs) via an emailed report card
PRO Integration into Clinical Practice: HCPs will document their discussion and recommendations/referrals in MiChart (Epic EMR)
|
Usual Care
Patients and HCPs will not receive an emailed PROMIS score report. PROMIS scores, however, will be available in the EMR as usual.
|
|---|---|---|
|
Overall Study
Cancelled appointment
|
1
|
0
|
|
Overall Study
Excluded due to technical difficulties with generating scorecard
|
8
|
0
|
|
Overall Study
Did not complete 12-week survey
|
16
|
16
|
Baseline Characteristics
Patient-Reported Outcomes Measurement Information System Integration Into Rheumatology Clinical Practice
Baseline characteristics by cohort
| Measure |
PRO Integration Into Clinical Practice
n=55 Participants
PRO scores will be shared with patients and healthcare providers (HCPs) via an emailed report card
PRO Integration into Clinical Practice: HCPs will document their discussion and recommendations/referrals in MiChart (Epic EMR)
|
Usual Care
n=55 Participants
Patients and HCPs will not receive an emailed PROMIS score report. PROMIS scores, however, will be available in the EMR as usual.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
55.2 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
53.5 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
PROMIS Domain Scores
Pain Intensity, 0-10 scale, where 0 is no pain and 10 is worst possible pain
|
5.2 score
STANDARD_DEVIATION 1.8 • n=5 Participants
|
5.5 score
STANDARD_DEVIATION 2.1 • n=7 Participants
|
5.3 score
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
PROMIS Domain Scores
Physical Function, T-score. A higher score indicates greater function.
|
38.2 score
STANDARD_DEVIATION 7.0 • n=5 Participants
|
37.7 score
STANDARD_DEVIATION 6.3 • n=7 Participants
|
37.9 score
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
PROMIS Domain Scores
Sleep Disturbance, T-score. A lower score indicates less disturbance.
|
58.2 score
STANDARD_DEVIATION 7.4 • n=5 Participants
|
57.1 score
STANDARD_DEVIATION 9.2 • n=7 Participants
|
57.6 score
STANDARD_DEVIATION 8.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: 1 appointment was cancelled and 8 were unable to receive score card due to technical difficulties.
Documentation in EMR notes will be categorized as either 'yes' or 'no' and identified through EMR data pulls. Percent of appointments is shown by the count (and percentage) of participants for whom PROMIS scores were documented in the EMR for their appointment.
Outcome measures
| Measure |
PRO Integration Into Clinical Practice
n=46 Participants
PRO scores will be shared with patients and healthcare providers (HCPs) via an emailed report card
PRO Integration into Clinical Practice: HCPs will document their discussion and recommendations/referrals in MiChart (Epic EMR)
|
Usual Care
n=55 Participants
Patients and HCPs will not receive an emailed PROMIS score report. PROMIS scores, however, will be available in the EMR as usual.
|
|---|---|---|
|
Percent of Appointments at Which Patient-Reported Outcomes Measurement Information System (PROMIS) Scores Are Documented in the Electronic Medical Record (EMR) Note by the Participating Health Care Provider (HCP)
|
23 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: 1 appointment was cancelled and 8 were unable to receive score card due to technical difficulties.
Documentation in EMR notes will be either 'yes' or 'no' and identified through EMR data pulls. Percent of appointments is shown by the count (and percentage) of participants for whom referrals were documented in the EMR.
Outcome measures
| Measure |
PRO Integration Into Clinical Practice
n=46 Participants
PRO scores will be shared with patients and healthcare providers (HCPs) via an emailed report card
PRO Integration into Clinical Practice: HCPs will document their discussion and recommendations/referrals in MiChart (Epic EMR)
|
Usual Care
n=55 Participants
Patients and HCPs will not receive an emailed PROMIS score report. PROMIS scores, however, will be available in the EMR as usual.
|
|---|---|---|
|
Percent of Appointments at Which Referrals/Recommendations Related to PROMIS Scores Are Documented in the EMR Note by the Participating HCP
|
17 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 2 weeksPopulation: Not all subjects completed every question. Some subjects skipped questions. In the usual care arm, no question was answered by more than 43 people.
Patient-provider communication is measured using the Interpersonal Processes of Care (IPC) Survey (29 items), which measures 7 subscales. For the subscales "elicited concerns/responded", "explained results/medications", "patient-centered decision making", and "compassionate, respectful" a higher score is better. For the subscales "hurried communication", "discrimination", and "disrespectful office staff" a lower score is better. (score for each subscale ranges from 1-5; + indicates a higher score is better, - indicates a lower score is better). Questions were not mandatory.
Outcome measures
| Measure |
PRO Integration Into Clinical Practice
n=35 Participants
PRO scores will be shared with patients and healthcare providers (HCPs) via an emailed report card
PRO Integration into Clinical Practice: HCPs will document their discussion and recommendations/referrals in MiChart (Epic EMR)
|
Usual Care
n=43 Participants
Patients and HCPs will not receive an emailed PROMIS score report. PROMIS scores, however, will be available in the EMR as usual.
|
|---|---|---|
|
Quality of Patient-provider Communication
Communication: Hurried communication (-)
|
1.3 score on a scale
Standard Deviation 0.5
|
1.2 score on a scale
Standard Deviation 0.5
|
|
Quality of Patient-provider Communication
Communication: Elicited concerns, responded (+)
|
4.1 score on a scale
Standard Deviation 1.3
|
4.5 score on a scale
Standard Deviation 1.0
|
|
Quality of Patient-provider Communication
Communication: Explained results, medications (+)
|
4.0 score on a scale
Standard Deviation 1.2
|
4.0 score on a scale
Standard Deviation 1.1
|
|
Quality of Patient-provider Communication
Decision making: Patient-centered decision (+)
|
4.0 score on a scale
Standard Deviation 1.3
|
4.0 score on a scale
Standard Deviation 1.3
|
|
Quality of Patient-provider Communication
Interpersonal style: Compassionate, respectful (+)
|
4.4 score on a scale
Standard Deviation 1.0
|
4.5 score on a scale
Standard Deviation 0.9
|
|
Quality of Patient-provider Communication
Interpersonal style: Discrimination (-)
|
1.1 score on a scale
Standard Deviation 0.4
|
1.0 score on a scale
Standard Deviation 0.2
|
|
Quality of Patient-provider Communication
Interpersonal style: Disrespectful office staff (-)
|
1.0 score on a scale
Standard Deviation 0.0
|
1.0 score on a scale
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: The most concerning domain for subjects in each arm was analyzed.
Change in score of PROMIS domain deemed most bothersome by each subject at baseline. Pain intensity is reported as a scaled score of 0-10, where 0 is no pain and 10 is the worst pain possible. Physical function and sleep disturbance are reported as T-scores. The scores in PROMIS measures are computed to a T-score metric, where 50 represents the mean for US general population, and 10 is the standard deviation. A higher PROMIS T-score represents more of the concept being measured, except physical function where a lower T-score indicates increased impairment. With physical function, a higher score indicates greater function and with sleep disturbance, a lower score indicates less disturbance.
Outcome measures
| Measure |
PRO Integration Into Clinical Practice
n=29 Participants
PRO scores will be shared with patients and healthcare providers (HCPs) via an emailed report card
PRO Integration into Clinical Practice: HCPs will document their discussion and recommendations/referrals in MiChart (Epic EMR)
|
Usual Care
n=39 Participants
Patients and HCPs will not receive an emailed PROMIS score report. PROMIS scores, however, will be available in the EMR as usual.
|
|---|---|---|
|
Change in Score of the Most Bothersome PROMIS Domain
Pain Intensity, 0-10 scale
|
-1.1 score
Standard Deviation 2.5
|
-0.9 score
Standard Deviation 2.4
|
|
Change in Score of the Most Bothersome PROMIS Domain
Physical Function, T-score. A higher score indicates higher function.
|
-0.5 score
Standard Deviation 2.6
|
1.1 score
Standard Deviation 4.8
|
|
Change in Score of the Most Bothersome PROMIS Domain
Sleep Disturbance, T-score. A lower score indicates less disturbance.
|
-2.8 score
Standard Deviation 6.6
|
-3.3 score
Standard Deviation 6.4
|
Adverse Events
PRO Integration Into Clinical Practice
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place